Non Carious Cervical LesionNCT04572386
Clinical Performance of Low Technique Sensitive Self Cured Universal Adhesive Vrs Light Cured Universal Adhesive in Patients With (NCCLs): 18 m RCT
A study testing light cure 3m single bond universal bond and Self-cure universal bond (Palfique, Tokuyama, Japan) in people with Non Carious Cervical Lesion, run by Aya Gamal ashour.
Trial summary
This study will be conducted to evaluate the clinical performance of self-cured adhesive versus light cured universal adhesive in non-carious cervical lesions (NCCL) resin composite restorations after 18 month Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Non Carious Cervical Lesion
- What is being tested?
- light cure 3m single bond universal bond and Self-cure universal bond (Palfique, Tokuyama, Japan)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- particepant with age rang 18-55
- particepant with non carious cervical lesion
Who cannot join
- particepant outside age rang
- particepant with periodontal problem that might affect the teeth to be treated
Trial locations and contacts
No sites are listed yet.
Rawda husien, Phd contact
About this study
Official title: Clinical Performance of Low Technique Sensitive Self-cured Universal Adhesive Versus Light Cured Universal Adhesive in Patients With Non-carious Cervical Lesions (NCCLs): 18 Month Randomized Clinical Trial
This study will be conducted to evaluate the clinical performance of self-cured adhesive versus light cured universal adhesive in non-carious cervical lesions (NCCL) resin composite restorations after 18 month
- Conditions
- Non Carious Cervical Lesion
- Being tested
- light cure 3m single bond universal bond, Self-cure universal bond (Palfique, Tokuyama, Japan)
- Keywords
- universal bond, NCCls, 3m single bond universal, Palfique, Tokuyama, Japan, self cure, non carious cervical lesions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
light cure 3m single bond universal bondOther
light -cure universal bond
Self-cure universal bond (Palfique, Tokuyama, Japan)Other
Self-cure universal bond with no light cure
| Study group | Role | What they receive |
|---|---|---|
| Light cure universal bond | Active comparator | light cured 3m single bond universal Receives: Other: light cure 3m single bond universal bond |
| self cure universal bond | Active comparator | self-cure universal bond (Palfique, Tokuyama, Japan) Receives: Other: Self-cure universal bond (Palfique, Tokuyama, Japan) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of fracture restoration
Frist visual evaluation to ensure that there is no complete loss of retention of the restoration then tactile evaluation will be done using probe tip that will be held gently at right angle to the labial surface and move from restoration to tooth and vice versa to insure no rocking /fracture /ditching in the restoration following FDI criteria ( first visually for total loss .followed by tactile inspection using fdi prob for any fracture /rocking or loss of retention
Measured: 18 month
number of restoration with retention loss
Frist visual evaluation to ensure that there is no complete loss of retention of the restoration then tactile evaluation will be done using probe tip that will be held gently at right angle to the labial surface and move from restoration to tooth and vice versa to insure no rocking /fracture /ditching in the restoration following FDI criteria
Measured: 18-month
Secondary outcomes (2)
Number of restoration with change in colour or texture
Evaluation will be done visually following FDI criteria to ensure no change in colour or texture of the restoration
Measured: 18 month
Number of restoration caused biological harm
Evaluation will be done following FDI criteria using FDI prob to ensure no change in restoration that caused any harm to the health of biological strucure
Measured: 18 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study startOct 2020 (estimated)
- Primary completionMay 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Carious Cervical LesionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aya Gamal ashour
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Aya Gamal ashour, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572386
- Sponsor's protocol ID
- gsda.1986.2
- Status last verified
- Sep 2020
- First submitted
- 11 Sep 2020
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Low Technique Sensitive Self-cured Universal Adhesive Versus Light Cured Universal Adhesive in Patients With Non-carious Cervical Lesions (NCCLs): 18 Month Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04572386
- Acronym / sponsor ID
- gsda.1986.2
- Conditions
- Non Carious Cervical Lesion
- Keywords
- universal bond, NCCls, 3m single bond universal, Palfique, Tokuyama, Japan, self cure, non carious cervical lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Aya Gamal ashourUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 1 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be conducted to evaluate the clinical performance of self-cured adhesive versus light cured universal adhesive in non-carious cervical lesions (NCCL) resin composite restorations after 18 month
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Light cure universal bond | Active comparator | Other: light cure 3m single bond universal bondlight cured 3m single bond universal |
| self cure universal bond | Active comparator | Other: Self-cure universal bond (Palfique, Tokuyama, Japan)self-cure universal bond (Palfique, Tokuyama, Japan) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- particepant with age rang 18-55
- particepant with non carious cervical lesion
Key exclusion criteria (2 listed)
- particepant outside age rang
- particepant with periodontal problem that might affect the teeth to be treated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| light cure 3m single bond universal bondlight -cure universal bond | Other | Light cure universal bond |
| Self-cure universal bond (Palfique, Tokuyama, Japan)Self-cure universal bond with no light cure | Other | self cure universal bond |
Primary outcome
Number of fracture restoration
Time frame: 18 month
Frist visual evaluation to ensure that there is no complete loss of retention of the restoration then tactile evaluation will be done using probe tip that will be held gently at right angle to the labial surface and move from restoration to tooth and vice versa to insure no rocking /fracture /ditching in the restoration following FDI criteria ( first visually for total loss .followed by tactile inspection using fdi prob for any fracture /rocking or loss of retention
number of restoration with retention loss
Time frame: 18-month
Frist visual evaluation to ensure that there is no complete loss of retention of the restoration then tactile evaluation will be done using probe tip that will be held gently at right angle to the labial surface and move from restoration to tooth and vice versa to insure no rocking /fracture /ditching in the restoration following FDI criteria
2 secondary outcomes
Number of restoration with change in colour or texture
Time frame: 18 month
Number of restoration caused biological harm
Time frame: 18 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rawda husien, Phd contact
Questions about this trial
What is this clinical trial studying?
A study testing light cure 3m single bond universal bond and Self-cure universal bond (Palfique, Tokuyama, Japan) in people with Non Carious Cervical Lesion, run by Aya Gamal ashour.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya Gamal, masters (01004222615, yoyo_ga@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of fracture restoration (time frame: 18 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.